University of Baltimore School of Law's Center for International and Comparative Law Fellows discuss international and comparative legal issues

Category Archives: United States

Should international views be given greater consideration in the interpretation of the evolving standards of the Eighth Amendment?

The United States has been pressured by the international community for its stance on capital punishment. This pressure has recently been reignited with the state of Arkansas announcing the execution of eight death row inmates in the span of ten days at the end of the month.[1] Although historically many nations exercised capital punishment, the majority of modern day states have either curbed or completely outlawed capital punishment.[2] In the case of S v. Kaywanyane and Another, South Africa’s highest court ruled that, “[e]veryone, including the most abominable of human beings, has a right to life, and capital punishment is therefore unconstitutional.”[3] Canada, after a five year moratorium, passed the C-84 bill, which abolished the death penalty.[4] As one of the prime leaders in the world for human rights movements, the international community has been puzzled by the United States’ archaic stance on capital punishment. Despite attempts to kick outside influence from our courts, we have seen such international influence creeping in starting as early as Paquete Habana. Even the heated topic of capital punishment has not been immune to international influence.

In Thompson v. Oklahoma[5], the Supreme Court found that the execution of an individual under the age of 16 would be a cruel and unusual punishment under the 8th Amendment’s contemporary standards of decency. The plurality talked about the “evolving standards of decency,” which was stated in Trop v. Dulles as an indicator of a “maturing society.”[6] To reach this evolving standard of decency, the court stated that it “is also consistent with the views expressed by… other nations that share the Anglo-American heritage” and additionally, “by the leading members of the Western European Community.”[7] The court even referred to three human rights treaties that prohibit juvenile capital punishment in the footnotes, specifically: Art. 6(5) of the International Covenant on Civil and Political Rights, Art. 4(5) of the American Convention on Human Rights, and Art. 68 of the Geneva Convention Relative to the Protection of Civilian Persons in Time of War.[8]

In Roper v. Simmons[9], the Supreme Court concluded that capital punishment for a juvenile is unconstitutional. While the court elaborated that international views “do not dictate the outcome of our Eighth Amendment inquiry” the court mentioned that the international community is “instructive for its interpretation of the Eight Amendment’s prohibition of ‘cruel and unusual punishments.’”[10] The court looked at various statistics in the world to point out that “only seven countries other than the United States have executed juvenile offenders since 1990.”[11]

In Atkins v. Virginia[12], the Supreme Court ruled that imposing the death penalty on mentally handicapped individuals would be a cruel and unusual punishment under the 8th Amendment. Even though the court relied on its conclusion based on only domestic findings, the majority mentioned in a footnote that the internationally community opposes capital punishment for mentally handicapped individuals[13]

To determine what constitutes cruel and unusual under the Eighth Amendment, our courts placed an emphasis on the “evolving standards” in our nation. Although there has been a lot of opposition on the use of international views to determine our constitutional rights, it is not a novel practice to have our courts cite international laws or sources, as shown throughout history. Through transnational seminars and conferences, legal dialogues between our judges and judges from around the world are increasingly common. From the cases observed here, the international views our courts referenced were not contrary to our values. In fact, our courts aligned with foreign views which brings up the idea that there is an international consensus against certain penal practices. Foreign law and international law, are still very persuasive laws.

It is time for the United States to re-examine our capital punishment policies with the international community’s views as a persuasive source. Even though our nation has shifted in the same direction as these abolitionist countries, the United States is in the minority where capital punishment is acceptable. Our nation joins a small group of countries who are regularly seen as one of the biggest human right violators, such as North Korea, Saudi Arabia, Iraq, China, Iran, and Egypt. Our capital punishment policy has been nothing but a failed project on criminal deterrence and its continued use is an international embarrassment. When our officials criticize other nations that have terrible human rights records, those countries deflect our criticisms and point out our archaic retentionist policies.[14]As a result, it would be in our nation’s best interest to re-examine the death penalty, with the international view as a persuasive source, and to persuade the Arkansas governor to halt the execution of these eight individuals, in light of the evolving standards of decency.

On April 1, 2017, the armed forces of Syrian President Bashar al-Assad launched a chemical weapon attack on a Syrian hospital.[1] Unfortunately, this attack is not the first instance of chemical warfare in the Syrian Civil War.[2]

Raging for the past six years, the Syrian Civil War has claimed the lives of hundreds of thousands of men, women, and children.[3] In 2012, then-President Barack Obama drew the non-infamous “redline”, claiming it would “change my calculus” if chemical weapons were used in the Syrian War. [4] While the Obama Administration appeared to be heading towards another intervention in the Middle East, the administration soon reversed itself, placing its hopes on a deal reached with the Russian Federation. In this 11th hour deal, the Russians were to oversee the destruction of President Assad’s chemical weapons.[5]

While the United States may well have avoided another Middle Eastern quagmire and may well have ceded prestige and influence to the Russians, the world largely watched the horror unfold as thousands of Syrian citizens were rendered helpless by chemical nerve agents. The world was horrified at the effects of the nerve agents, and yet the world continued with business as usual.

Just as then-President Obama was torn between military intervention in the Syrian Civil War and non-intervention, President Trump is torn between intervening in a years-long war and remaining on the sidelines. Even though candidate Trump campaigned on an “American First” platform, consistently claiming he was against the Second Iraq War from the beginning, the President must understand that America must stand for the non-use of chemical or biologic weapons against citizens, or even on the battlefield.

America, from its founding, has stood for the universal rights of freedom and self-determination, enshrined in our Declaration of Independence from George III, chief among them, life, liberty, and the pursuit of happiness. While, like all nations, the history of the United States is tainted with horrific episodes, the United States stands for human rights. In the history of the world, the United States is one of the only, if not the only, nation that fought a brutal civil war to set other men free from bondage.

Furthermore, the United States, and its allies, fought two World Wars under the principles of self-determination and freedom from tyranny, persecution, and genocide. From the ashes of the Second World War rose the United Nations. That institution too, seems incapable of stopping Assad’s gas attacks.

Protected by the Chinese and Russian veto, the Syrian government will probably never pay for its gross violation of international law and the laws of war. This then begs the question: if the United Nations is no longer an institution capable of protecting the innocent, then what is its purpose in its current form? What would make this institution capable of truly bringing violators to justice and face the consequences of their actions?

There has been some discussion on reforming the United Nations Security Council. In what form would such an arrangement take? Would there be any permanent members removed from their permanent positions? Who would take their place? In the event present permanent members are not removed, what members would receive permanent membership? Finally, how would that affect the veto powers?

Some have offered the addition of the “BRIC(S)” as permanent members to the Security Council, minus the already-permanent members of Russia and China. As the leading emerging economies Brazil, India, and South Africa would receive permanent status as well as a veto.

As the largest country in South America, Brazil would add diversity to the Council, as it would be the only permanent member from South America. As another emerging economy with a large population, and a democracy, India would be a leading candidate to receive permanent status. However, given various geopolitical concerns, China would likely vocally oppose any such appointment to the Security Council’s permanent members. Pakistan, India’s longtime rival, would oppose such an appointment as well. Given the absence of an African voice on a permanent basis, South Africa would probably receive the veto and permanent status.But the question would then turn to the following: given the dilution of the veto, what would be its power?

Would the United Nations determine that since there would be as many as eight members, would any veto require just one permanent member to halt a resolution, or would two members be necessary? Could this body become more democratic, with “majority rule” be the rule? If that is the case, how would the decidedly non-democratic states of Russia and China respond? They could, one could plausibly foresee, cut back on their involvement in the Security Council, deciding that they no longer have as much of a stake in the body.

While the United Nations has been unable to protect the innocent in conflicts like Rwanda, the Sudan, Syria, or Eastern Ukraine, the UN must reevaluate its work. The United Nations appears paralyzed and incapable of living up to providing for peace and prosperity for all nations. Perhaps a remedy for this apparent paralysis could include more permanent members of the Security Council while revising the current rules regarding the veto powers of the permanent members.

While the United Nations expressed outrage as from this most recent chemical weapons attack against an innocent civilian population, the UN has not taken any concrete actions against Bashar al-Assad. While President Trump campaigned on an “America First” platform, the president’s most recent actions[6] are polar opposites of such a course. United Nations Ambassador Nikki Haley stated that, regime change in Syria is “inevitable.”[7]

It appears that President Trump is evolving in his new role as commander in chief and as leader of the free world. From campaigning on an “America First” platform to his strikes against Syria, and the dispatching of the USS Carl Vinson strike group to the Korean Peninsula, President Trump has shown he is willing to use military force to further the interests of the United States in the absence of United Nations action.[8]

Bradley Willis is a 3L at the University of Baltimore School of Law. He graduated from the University of Delaware (2014) with a Bachelor of Arts in Political Science and minors in History and French and studied abroad in Caen, France. His areas of interest are international relations, history, politics, and the laws of war. Bradley spent a semester externing with the Hermina Law Group, researching and writing sovereign immunity issues as well as embassy law. Last year, he participated in the Philip C. Jessup Moot Court Competition. He is currently a law clerk for the Law Office of David B. Love, P.A.

In the growing age of globalization and the rise in the use of technology, many have difficulties disconnecting from work. Smartphones have replaced the computer, the newspaper, the telephone, and much more. We are always connected, and that connection is just as tied to our employer as it is to our personal lives. Companies are starting to realize that their employees health and production have been negatively effected. One country has taken the initial steps necessary to reestablish the wall between employees’ personal and work life.[i]

On May 10, 2016, the French government used a constitutional provision to push through the El Khomri law. The law is named after Labor Minister Myriam El Khomri. Many provisions in the law were seen to benefit employers at the expense of employees, and therefore not welcomed by the French people. However, the most well liked article had the employees’ needs in mind. The law went into effect on January 1, 2017, in which France now requires employers to negotiate what rights their employees have to ignore work emails and other forms of communication. While the idea is commendable and its expected effects laudable, the complete lack of an enforceability mechanism in the law is an issue but that does not take away from the effect it can have on employees.

The right not to disconnect requires employers to negotiate what those specific rights would be for their employees, however, if the employer fails to do so, or breaks the terms of that right there is no mechanism to penalize the employer. This leaves employees in an odd place, they have a right but no means to enforce that right. It will be interesting to see if courts will take action if case is brought.

For the rest of the world, however, employees still have to dread whether that vibrating phone is a friend or their employer, which can increase their stress levels. This stress can lead to what experts are calling “digital exhaustion.”[iii] Employers have taken this researched and asked themselves to consider the effect that being tied to your email can have on the overall productivity of that employee. For example, the productivity levels in the United Kingdom are poor not only because U.K. citizens work the longest hours in Europe but also due to the fact that U.K. citizens are biggest users smart devices.[iv] Britons work an average of eight and half hours a day, which equates to 1677 average annual hours with £18.64 hourly productivity.[v] A Luxembourger, by comparison, works about 1643 average annual hours, with £45.71 hourly productivity.[vi]

While the average annual hours are relatively close, the hourly productivity numbers are drastically different. This could be because not only do Britons work longer hours, but also cannot disconnect from work once they leave. Although this study was looking at the number hours worked, it could be interesting to see how many hours Britons work when not on the clock. I suspect the average annual hours would rise and the amount hourly productivity would decrease even more. However, France and England are not the only countries facing this dilemma.

In 2015, a Japanese company, Dentsu, an employee committed suicide after working over 105 overtime hours in a month.[viii] In response, Tokyo’s governor ordered government employees to end their day by 8 PM.[ix] Additionally, Dentsu has since barred workers from putting in more than 65 hours of overtime a month. Japan may need to follow suit with France’s law to help further disconnect their over worked employees.

This issue of needing to disconnect can affect more than the happiness of the employees. In South Korea, employees are working so much that they are not taking time to have families. Thus, in response South Korea’s Ministry of Health introduced a monthly Family Day, where the office lights are turned off at 7 PM to encourage staff either to spend time with their families or to use that time to create a family. The Ministry had the goal of increasing South Korea low birth rate.[x]

As globalization continues and as we stay more connected than ever, the labor laws of countries need to adapt. Employees are spending all their time increasing the profits of their employer without seeing added benefits for that work. Overall, countries need to realize that their citizenry are not there to be cogs in the machine, but to build their lives as they see fit, which means being able to have lives outside their employment.

Robert Steininger is a third year law student at the University of Baltimore School of Law. (Candidate for J.D., May 2017). He holds a Bachelors of Arts in Linguistics with a minor in Japanese from the University at Buffalo – SUNY. As part of his international law studies, he took part in a winter study abroad program in Curaçao taking classes in European Union Economic law and Comparative Confession law. He also studied in Japan at Konan University while completing his undergraduate degree. In addition to being a CICL fellow, Robert currently serves as the Volume V Managing Editor for the University of Baltimore’s Journal of International Law and the President of OUT Law. He is also a Maryland Rule 19-217 Student Attorney with the Immigrant Rights Clinic. He is currently a Law Clerk at the American Federation of Government Employees, AFL-CIO.

A United States drone strikes a car near a gas station in Syria.[1] Inside that car, Junaid Hussain lays lifeless.[2] Though a seemingly normal 21-year-old British man with an education and a wife, Junaid possessed exceptional computer hacking skills and ties to ISIS’s cyber division.[3] Instead of the United States sending a sniper to take out Junaid, a person used his or her trigger finger to direct the drone strike from a computer miles away from the gas station.[4] Throughout history, technology has drastically changed warfare. The advances in cyberspace technology are no exception and the law is struggling to keep up.

While country-on-country cyber-attacks have made headlines in the 21st century, such attacks can be dated as far back as the Cold War.[5] In June 1984, a United States satellite detected a large blast in Siberia.[6] That blast turned out to be an explosion on a Soviet gas pipeline.[7] A malfunction in the computer-controlled system that the Soviets stole from a firm in Canada caused the explosion.[8] Unware to them, the CIA caused the malfunction by tampering with the software, resetting the pump and valve settings to produce pressures far beyond the capabilities of the pipeline welds, which ultimately resulted in destruction.[9]

The most recent and controversial cyber-attack resulted in WikiLeaks publishing a series of confidential emails exchanged between several key members of the Democratic National Committee.[10] The release negatively impacted the Democratic Party in the public eye and resulted in the call for resignation from the DNC chairperson, the CEO, the CFO, and the Communications Director.[11] Despite President Trump’s initial accusation, these hackers are not just 400 pound guys in a basement; they are sophisticated and, potentially, dangerous adversarial governments.[12]

The United States accused Russian President Vladimir Putin of ordering an “influence campaign” aimed at weakening Hilary Clinton’s campaign and strengthening Donald Trump’s.[13] The campaign consisted of hacking Democratic groups and individuals and releasing that information via third party websites, including WikiLeaks.[14] Intelligence agencies concluded with high confidence that Russia had intended to undermine American faith in the electoral system by hurting Hilary Clinton’s chances of winning.[15] As a result, in December 2016, America responded with what was arguably its strongest response yet to a state sponsored cyberattack.[16] “All Americans should be alarmed by Russia’s actions” stated Former President Obama.[17] While there is partisan disagreement about the scope and intent of the Russian cyber-attack on the 2016 United States Presidential Election, 77% of Americans from a wide variety of political backgrounds believe that cyber-attacks against computer systems in the United States are a serious threat.[18] Meanwhile, 63% of Americans believe that the United States is not adequately prepared to deal with these cyber threats.[19]

While President Trump has repeatedly stated that the Russian hacking had no influence on the outcome of the election, it is becoming clear that cyber-attacks are becoming more prevalent and powerful.[20] Intelligence agencies reported that the Russian election intervention is an old-fashioned Soviet-style propaganda campaign made more powerful by the tools of cyberage.[21] While it may seem like this was a onetime event and new attack, it was actually a part of a campaign that went undetected for years.[22]

The same international laws apply to cyberspace as they do to traditional warfare domains. Yet, cyber-attacks are difficult for the international community to analyze due to their complexity and secrecy. In response to this challenge, the NATO Cyber Centre wrote the Tallinn Manual on the International Law Applicable to Cyber Warfare.[23] Applying the principles of the international law of war in cyberspace, the manual has been the primary guide for armed conflicts.[24] According to the principles in the manual, the Russian cyber-attacks on the DNC are below the threshold of an armed conflict.[25] On the other hand, if Russia had destroyed America’s cyber infrastructure, it would likely be enough to be a use of force and thus a violation.[26]

Yet others experts, such as the chairman of the U.S. Naval War College’s international law department Michael Schmidt, believe that the DNC hack was in fact a violation of international law.[27] For example, the hack could have threatened U.S. sovereignty.[28] The hackers attempted to intervene into the internal fairs of the United States affairs, which includes running elections.[29] However, there would need to be proof that Russia not only stole information but used the information to manipulate election results.[30]

Therefore, the DNC hacks still lie in a legal gray zone. While the Tallinn Manual provides excellent guidance on applying international law in cyberspace, the Tallinn Manual 2.0 is in the works to expand upon it.[31] The goal of this additional manual is to examine how international law applies to cyber-attacks below the threshold on an armed conflict.[32] Until then, clever nations will continue to use cyber-attacks, like the DNC hack, to cause harmful effects but not cross the line that would trigger an armed response.[33]

Elizabeth Hays is a third year law student at the University of Baltimore School of Law. She completed her undergraduate studies at the University of Baltimore, where she majored in Jurisprudence. Her legal interests include administrative law, national security law, and maritime law. Elizabeth has previously interned with the U.S. Army JAG Corps and the U.S. Coast Guard JAG Corps. Additionally, she participated in the winter study abroad program in Curaçao in 2015/16. She is currently the Co-President of University of Baltimore Students for Public Interest (UBSPI) and a Staff Editor for University of Baltimore Law Forum.

The mystique of a dystopian society has maintained a consistent intrigue across the history of mankind. The imagination of man runs wild when he thinks about the “what ifs” and how they would affect the way we live.

The Time Machine; 1984; Brave New World; Planet of the Apes; The Giver; The Hunger Games; The Divergent Series; and, of course, that paramount episode of The Twilight Zone when all that poor man wanted to do was read his books – he becomes the last man on Earth and can finally sit on the remains of the post-apocalyptic library, reading for the rest of his days. And then, he accidentally steps on his glasses and yells, “That’s not fair, there was time now!”

We have seen the same theme time and again: mankind begins to self-destruct and in the bout of chaos and anarchy, a powerful leader/governing body rises from the ruins and reshapes society into a peaceful and balanced ecosystem. Beautiful, no? So, what’s the catch? To have order and peace, one must forego the right to freedom and privacy.

My friends, hold on to your Mockingjay pins, for the dawning of the dystopian society may be upon us.

On November 29, 2016, The Investigatory Powers Act (IPA) was passed in the UK set to be enforced in January 2017.[i]Not the first of its kind among the EU Member States, the IPA was satirically dubbed the “Snooper’s Charter” by those who opposed it. The Act grants law enforcement easier access to the private communications of UK citizens.[ii] Some of the major provisions[iii] include, but are not limited to:

Power to issue warrants for intrusive surveillance granted to ministers.

Easier access for the government to retain browser history from popular websites.

Over the past few years, terrorist attacks have become a consistent and troubling threat throughout Europe.[iv] Although aware of the threat posed by terrorism, many within the EU are concerned since allowing the government into their phones and personal computers was not quite what many had in mind, as far protective measures go.[v]Amnesty International (AI) criticized the UK, a nation considered to be a fierce protector of human rights, for setting such an example to other EU-Member States.[vi] According to AI, the Snooper’sCharter is “a modern twist of the Orwellian ‘thought crime,’ [in which] people can now be prosecuted for actions that have extremely tenuous links to actual criminal behavior.”[vii]

I sympathize and empathize with this issue under two lenses: the first,my rose-colored-goggles human rights activist perspective, in which I feel the rights of the people should be staunchly protected and the foremost concern of the governing body to any nation because it is what is just and humane; and the second, as a young American adult who remembers being a nine-year old, enveloped with gut-wrenching fear for reasons I could not even comprehend, living just minutes from Washington D.C. on September 11, 2001, and seeing the glazed-over eyes and clenched jaws of my peers whose parents worked downtown trying to hold back their tears in school for weeks following the attack.

The day the government is definitively tracking every communication we send and receive will be a disturbing one for sure. Even if they have nothing to hide, many people are bothered knowing a third party is always reading, analyzing, and judging everything they type or say.

While freedom of speech is of the utmost importance, I continually find myself reverting to the lenses of nine-year old me. If the ones I love are at risk of being hurt, I would give up my right to privacy within the confines of this act. Maybe not permanently – and that is a risk that holds high with a law challenging a fundamental freedom – but at least until this state of emergency in Europe eases.

Think about The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (far more commonly known as The USA PATRIOT Act) enacted during the George W. Bush Administration in 2001 following the 9/11 attacks which enabled law enforcement to detect and prevent terrorism attacks by expanding the scope of their investigatory practices.[viii] The USA PATRIOT Act passed in Congress across the bipartisan margins.[ix]In the Senate, the act passed with nearly a unanimous at a 98-1 vote, while the House voted in favor with a 357-66 vote.[x]

Regarding terrorist attacks, the US has not faced an attack of the magnitude of 9/11 since the act was decreed. While the USA PATRIOT Act has its flaws, as most laws do, the original purpose for introducing the bill has generally been satisfied. The UK appears as if the IPA has received the same treatment by Parliament.[xi] According to London-based journalist, Ewen MacAskill, the bill passed “with barely a whimper.”[xii] Further, he said the marginal resistance to the bill did not come from outside of the parliament’s four walls, indicating the people of the UK and Parliament are both in support of the IPA.[xiii] If the citizens of the UK are not complaining about the new law and choosing to exercise their right of privacy by foregoing their right of privacy, then so be it. They have the right to invite Big Brother into their lives.

“To the future or to the past, to a time when thought is free, when men are different from one another and do not live alone – to a time when truth exists and what is done cannot be undone…from the age of Big Brother – greetings!” – George Orwell, 1984[xiv]

Margery Beltran is a third year law student at the University of Baltimore School of Law (Candidate for J.D., May 2017). She holds a Bachelor of Science in Family Science with a minor in Psychology from Towson University. Her interests include mental health and disability law and international alternative dispute resolution. Margie currently serves as the Volume V Comments Editor for the University of Baltimore’s Journal of International Law. She participated in the 2016 Summer Abroad Program at the University of Aberdeen School of Law in Aberdeen, Scotland. She is currently an intern in Washington D.C. for the U.S. Department of Health and Human Services, Alternative Dispute Resolution Division.

On December 2012, the Second Circuit of the U.S. ruled in favor of the defendant in U.S. v. Caronia, stating that the non-misleading speech of off-label[1] promotion by a pharmaceutical representative is protected by the First Amendment. The case drew nationwide attention by pharmaceutical companies, public health scholars, government officials, and health lawyers. Many worried that First Amendment protections trumped public safety in off-label promotion. While the actual ramifications are debatable, Caronia certainly warrants further inquiry. After all, the U.S. is not the only country where off-label prescription and promotion of medications take place. From France to Germany to Japan to India, off-label prescriptions and policies thereof exist, and while most of the policies are similar on the overarching principles, the subtle nuances reflect an ulterior motive that may or may not be noble. Many nations of the world have different yet very similar approaches to off-label prescription use regulation.

The Caronia case arose out of the promotion of a drug called Xyrem, a very powerful central nervous system depressant.[2] The Food and Drug Administration (FDA) deemed the medication’s side effects so severe that the drug warranted a black box warning, the most serious kind of warning the FDA may give.[3] Caronia and Dr. Peter Gleason, representatives for Xyrem’s manufacturer, promoted an off-label use; Gleason said he personally treated patients far younger and older than the approved scope of use. However, the court found that the actual speech of the off-label promotion is protected. In the U.S., off- label promotion is not inherently illegal, but off-label promotion may be used as evidence of misbranding, which is illegal.[4] However, the U.S. does not entirely prohibit all kinds of off-label promotion. In fact, the system is set-up such that pharmaceutical manufacturers may fund research that helps find new off-label uses. The manufacturers may then disseminate the research results.[5] Many concerns arise from Caronia’s ruling: manufacturers will start promoting, while disregarding public safety; research will no longer be funded; the FDA will be limited in power, and so forth. However, the U.S. is not the only country to tackle the issue of off-label prescription use.

Off-label use is not a rare phenomenon and nor is it exclusive to the U.S. In fact, off-label use is a very common medical technique used to treat numerous patients worldwide. In Paris, a statistical study suggests that nearly 62% of prescriptions are for an unauthorized use.[6] In the first quarter of 1999, nearly 13% of all prescriptions for children and adolescents in Germany were prescribed off-label.[7] Similarly, 22 German medical centers said off-label use was “common” for a vast majority of the physicians.[8] In Spain, 61% of pediatric physicians prescribe for medications in an off-label manner.[9]

Yet, how each nation regulates off-label use and the public policies that stem therefrom differ in only the subtlest of ways.The European Union (EU) has established a general policy for off-label use; drugs should be approved and authorized for specific treatments. However, the EU also believes that its Member States should incentivize further research. One possible incentive is a six-month extension to a Supplementary Protection Certificate,[10] extending a manufacturer’s exclusive property rights.[11] Second, the manufacturer is granted an extra two years of market exclusivity if research is done on a drug that affects less than 5 in 10,000 patients or has become a drug where, without incentives, no pharmaceutical company would want to conduct further research for lack of a justification to the necessary investment of research but the drug still holds potential to treat a condition that otherwise cannot be treated with alternative medicines – also called an orphan drug.[12] The EU did not want “rigid and compelling legal regulations” but a system of incentives to nurture the desire for research over penalizing the lack thereof.[13] This desire stems from the need for pediatric research. Nearly 21% of the EU’s population – nearly 100 million – are vulnerable children with inadequate drug supply.[14] In fact, 50% of medications were never even tested for children before becoming orphan drugs.[15] However, many of the Member States are silent on the issue of off-label prescription in their legislation, relying mostly on the EU. On the other hand, France has a very specific approach that defies the EU’s principles.

In France, a manufacturer may apply for a “temporary recommendations for use” (RTU) application with the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). A RTU allows manufacturers to promote a current drug for an off-label use for 3 years. However, this approval is a contractual relationship; upon approval, the manufacturer is legally obligated to scientifically observe and evaluate the affected population.[16] To obtain a RTU, the manufacturer must prove that no other viable treatment for a current disease except for the off-label use of the drug in question.[17] This approach places the burden on the manufacturer, with much less incentive than the EU’s approach. Yet, there are other approaches in the world warrant further analysis. For example, in India, off-label use of any kind is strictly prohibited without exception.[18] In Japan, if the medication is for certain diseases, it can be approved for off-label use without the “preliminary clinical evidence of [the drug’s] effectiveness.”[19] So, approaches vary greatly between nations.

More importantly, the underlying policy behind these regulations – or lack thereof – must be assessed. In the U.S., the ability to prescribe for off-label use is a necessary “corollary of the FDA’s mission to regulate pharmaceuticals.”[20] The goals of pharmaceutical regulation are to protect the public safety, ensure a drug benefits specific patients groups as well as the overall population, and ensuring justice and equity in patients’ access to safe and effective drugs.[21] The regulation of drugs is specifically to ensure that physicians know that off-label use is prescribing a drug for a use that the “regulatory body has not stated is safe and effective.”[22] While these are very noble goals, a nation must not forget that off-label use is integral in medicine since many market drugs have no labeling or approved uses for specific populations.[23] For example, in Calabria, “less than 15%” of all the drugs on their market are meant for children on the basis of clinical trials.[24] While many people also fear off-label use for its inherent risks, the use of medicine is always a balancing act of benefit vs. risk. The FDA’s drug approval process requires drugs to be “safe and effective,” with the definition of safety changing on a case-by-case basis.[25] Drugs cannot always be completely void of risks, which is why a balancing act is necessary. However, if all off-label use is prohibited (as it is in India) or, arguably, greatly stifled (like in France), then it is impossible to do a risk-benefit analysis since there is no chance to know of the benefits.[26] Therefore, a careful analysis of which underlying principle to adopt is necessary.

The EU’s incentive approach certainly drives more research because there is seldom a greater incentive than financial. However, France’s approach to patient safety and care – while noble – places a greater burden on drug manufacturers without necessarily promising greater investment returns. However, if patient safety were the only concern, perhaps India’s approach to absolute prohibition would be the best, forcing manufacturers to conduct research for each and every possible use. Yet, Japan’s take could also allow much needed access to medications that would otherwise be either unavailable or not covered by insurance.[27] In the U.S., the approach is to allow research funding but not off-label promotion directly by the manufacturer. Each nation has a specific approach but what is truly at hand is the underlying idea of why each regulation is – or is not – viable. Indeed, it is a balancing act between the public safety, the preservation of regulatory authority, incentivizing research, keeping the manufacturers liable, and ensuring patient access to much needed drugs. Certainly, there is no one true answer – merely a set of ideas that should be adopted only after a nation knows what would be best for its people.

Jasen Lau is a third year law student at the University of Baltimore School of Law. He graduated from the University of Maryland in 2013 with a Bachelor of Arts in English. Jasen took it upon himself to become a certified pharmacy technician and studied several continuing education credits that focus on Medicare Fraud and Abuse prevention, HIPAA privacy and security laws, and ethics in the pharmacy workplace. Jasen has long been in the health care field either working directly with patients or as an assistant to providers. During that time, his obsession with working in health care has grown into policy analysis and counseling. Along with being a CICL fellow, he is also a law clerk for Johns Hopkins Hospital.

[1] The term “off-label” is defined as any use that is not authorized by the FDA.

[5] Mariestela Buhay, Off-Label Drug Promotion Is Lost in Translation: A Prescription for A Public Health Approach to Regulating the Pharmaceutical Industry’s Right to Market and Sell Its Products, 13 J. Health Care L. & Pol’y 459, 488 (2010).

[8] N. Ditsch, et al., Off-label use in germany – a current appraisal of gynaecologic university departments, 16 European J. Med. Res. 7 (2011) (22 medical centers responded to a questionnaire, and of those physicians who responded, 91% said they commonly prescribed off-label use medications).

[27] Ditsch, supra; Pérez, supra; see also E. L. Trimble, et al., International models of investigator-initiated trials: implications for Japan, 23 Annals of Oncology 3151 (2012) (In all nations, unless some form of off-label use is either properly documented or approved, the state health insurance will not cover the medication).

Hisham Shaban Galia traveled ten thousand miles to reach the United States, where he sought asylum.[1] Shaban was escaping the violence that plagued his home in the Gaza Strip, facing violence from both Hamas and Israel.[2] His asylum claim was denied because he failed to meet his evidentiary burden of producing documents to support his claim; he had represented himself pro se.[3] For the past sixteen months, Shaban has been held at an immigration detention facility in Arizona.[4] While Immigration and Customs Enforcement (ICE) has determined that Shaban cannot stay in the country, the fact that his home – Palestine – is no longer considered a state poses a problem: how can the U.S. deport someone to a state that, under the eyes of U.S. law, does not exist?[5] Shaban has since obtained counsel from the non-profit, the Council on American-Islamic relations.[6] His counsel, Liban Yousef, filed a habeas corpus petition for supervised release; if granted, this would allow Shaban to have the opportunity to work.[7] While the petition is still being reviewed, ICE released a “Decision to Continue Detention.”[8] Shaban fears that he will spend his life in the limbo of the detention center, having already spent over five hundred days there.[9] While his case appears unusual, the war-torn Gaza Strip is likely to produce more asylum seekers with similar backgrounds who will be difficult to deport under U.S. law.

Palestine and Israel territory over the past 70 years

The Universal Declaration of Human Rights states in Article 15 that everyone has the right to a nationality.[10] The history of Palestine is an interesting one: formerly seen as a “home for stateless Jews” in 1947, Palestine now finds itself in the reverse position: Israel has attained statehood, and Palestine has lost its status.[11]

There are four requirements for statehood.[12] First, there must be a population; this means that the alleged state must have people there.[13] Second, a state must have territory, meaning it must be based on some land.[14] Third, the state must have some government; in other words, there has to be some entity making the laws.[15] Finally, a state must have the capacity to enter into international relations.[16] This last requirement acts as a less-objective test and a safeguard for when the international community does not want to recognize a state. By not engaging with that would-be state, the international community can reinforce the idea that the entity is not a state.

There are about fifteen million stateless people worldwide, and the number is growing.[17] Based on the estimates provided by the United Nations High Commissioner for Refugees, Palestinians make up one-third of the stateless people worldwide.[18] Vicent Chetail writes that the Refugee laws for Palestinians are very strict.[19] While Shaban entered the U.S. for the legal purpose of requesting asylum, most Palestinian refugees are only able to enter other countries through illegal means.[20] In the United States, there are about 1,087 asylum seekers reported; however, given their lack of rights and access to resources, the number of asylum seekers in the U.S. is likely significantly greater.[21]

Shaban is not the first – nor will he be the last – Palestinian that the U.S. holds for deportation. When ICE was questioned on how Palestinians have been deported in the past, it asserted that it has coordinated with Israel, Egypt, and Jordan.[22] However, Shaban’s deportation officer gave him the option of being deported to Pakistan, Afghanistan, Malaysia, or Iraq.[23] Shaban has never been to any of these countries, and considered that this might be a threat; even so, he said he would go anywhere as long as he was no longer in detention.[24]

In addition to the practical conundrum that follows the attempt to deport a stateless person, there are also considerable legal concerns surrounding the international rights of people like Shaban. Article 31 of the UN Refugee Convention (1951) clearly states that no signatory shall impose penalties on refugees because of their illegal status, given the dire situations these refugees are fleeing.[25] The U.S., however, did not sign the Convention, but did sign the 1967 Protocol.[26] The Protocol appeared to retain the substantive portions of the 1951 Convention, and only removed the temporal and geographic restrictions, which focused mainly on events occurring in Europe.[27] Still, Chetail explained that the international community’s application of this Convention is problematic, as deportation should be used as a last resort and not a deterrent.[28] Shaban’s lawyer also alleges that the detention is unconstitutional, as it violates his client’s right to due process.[29] While statelessness is not a crime – in contrast, it is a mark of vulnerability – Shaban has remained in detention after being deemed inadmissible to the United States.[30]

Campaign to support the release of Hisham and Mounis Hammouda, also in detention

U.S. domestic law is not silent on the issue, either. The facts of Shaban’s case, as well as the cases of those like him, run directly contrary to the spirit of Zadvydas v. Davis.[31] The U.S. Supreme Court heard the facts pertaining to Kestutis Zadvydas’s detention. Zadvydas was born to Lithuanian parents in a German camp for displaced persons.[32] Neither Germany nor Lithuania would accept him upon deportation.[33] He was ordered to be deported due to his criminal record.[34] The removal period for aliens held in custody was ninety days.[35] After the ninety days passed, Zadvydas filed a writ of habeas corpus.[36] Justice Breyer, writing for the majority, expressed concerns over the constitutionality of a statute that would allow indefinite detention, writing that it is inconsistent with the Due Process Clause.[37] If one is to rely on stare decisis, it is evident that U.S. law does not permit holding Palestinians like Shaban indefinitely. Furthermore, during oral arguments, Justice Scalia had asserted that the burden of finding a country to be deported to lies with the petitioner.[38] Even if this is the standard for petitioners to meet, Shaban has already met it by wishing to be deported to his state of Palestine.[39] The conundrum lies in the refusal of the U.S. to recognize Palestine as a state, and its refusal to employ any alternative that would release Palestinian asylum seekers from indefinite detention.

Alison Aminzadeh is a third year law student at the University of Baltimore. She is currently a Rule 16 attorney working on the Human Trafficking Project as a part of the Civil Advocacy Clinic. She is also a Senior Staff Editor for the Journal of International Law, and the former President of the Students Supporting the Women’s Law Center.

[26] Convention Relating to the Status of Refugees, 606 U.N.T.S. 267 (1951, 1967); States Parties to the 1951 Convention relating to the Status of Refugees and the 1967 Protocol, UN High Commissioner on for Refugees (last accessed Apr. 10, 2016), available at http://www.unhcr.org/3b73b0d63.html.